A Transplant or Cancer Resilience Intervention

NCT ID: NCT01629069

Last Updated: 2014-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-05-31

Brief Summary

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The overall aim of this protocol is to examine patient and care-giver outcomes and acceptance of a new 6 week intervention in Arizona for our transplant and cancer patients and their care-givers, designed to improve quality of life, decrease perceived stress, and improve medical outcomes, that has been approved as a pilot clinical program at Mayo Clinic in Arizona.

Detailed Description

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Transplant medicine and cancer are major strategic foci of Mayo Clinic. At Mayo Clinic, we are often challenged to respond adequately to the high levels of stress encountered by our transplant patients and their care-givers. The overall aim of this project is to pilot a 6 session intervention in Arizona for our transplant and cancer patients and their care-givers, designed to improve quality of life, decrease perceived stress, and improve medical outcomes. Demonstration of a feasible and effective program will allow us to offer similar programs at all three sites. This program has potential to better meet our transplant patients' needs, improve outcomes, and set us apart from other transplant programs who do not offer this intervention for patients and caregivers. Psychiatry already has a good collaboration with transplant medicine, with psychiatry screening transplant patients and following a large subset of patients. Many of the referrals to psychiatry post-transplant have to do with difficulty managing stress or break-down in care-giver support. The proposed program would address this unmet need with a more comprehensive intervention than is currently available at the Mayo Clinic. The role of this pilot program is to:

* Explore the feasibility of routinely offering a resilience intervention involving mindfulness based stress reduction to our solid organ and stem-cell transplant and cancer patients and their care-givers.
* Pilot a mindfulness-based group treatment for stress reduction to assess its impact, using standardized rating tools, on transplant patient stress-levels, sleep quality, anxiety, depression, medical outcomes, and health-care utilization
* Examine patient and care-giver acceptance/adherence and satisfaction
* Understand the resources both in terms of staffing and fees required to offer this as a clinical program in the future
* Explore the reimbursement options for covering the program's expenses.

Conditions

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Behavior Emotions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Participant in MBRT

6 sessions of Mindfulness Based Resilience Training

Group Type ACTIVE_COMPARATOR

Mindfulness based Resilience Training

Intervention Type BEHAVIORAL

6 weekly group sessions

Interventions

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Mindfulness based Resilience Training

6 weekly group sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patient listed for liver, heart, kidney, or bone marrow transplant
* Patient who has received a liver, heart, kidney, or bone marrow transplant
* Caregiver of transplant patient
* patient with diagnosis of cancer, either active or in remission
* supportive care partner of cancer patient

Exclusion Criteria

* Suicidal
* Severe cognitive impairment
* psychotic
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Cynthia M. Stonnington, M.D.

Chair, Department of Psychiatry & Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia Stonnington, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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12-004988

Identifier Type: -

Identifier Source: org_study_id

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